Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe
FDA 510(k) K013244 · Med Gen, Inc.
510(k) numberK013244
Submission
- Device name
- Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe
- Applicant
- Med Gen, Inc.
Boca Raton, FL, US - Received
- September 28, 2001
- Decision date
- December 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQM – Bandage, Elastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5075
- Specialty
- General Hospital
Other 510(k)s with product code FQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040936 | Petit Silma Elastic Bandage with Germanium/Titanium OxideFQM · Traditional | Leda Co., Ltd. | 05/03/2004SE |
| K040054 | Back in Action Compression & Support with Magnets for the Lower Back, Knee and AnkleFQM · Traditional | Theodore Barash | 04/27/2004SE |
| K952738 | Skin Saver SystemsFQM · Traditional | Skin Saver Systems, Inc. | 09/29/1995SE |
| K872868 | Aspen Esmark BandageFQM · Traditional | Aspen Laboratories, Inc. | 07/31/1987SE |
| K840107 | Tube-Bandage for Human Digits 200FQM · Traditional | Zens Health Care Products | 04/25/1984SE |
| K831728 | MedicalexFQM · Traditional | Medicalex | 01/09/1984SE |
| K830622 | Ortho WrapFQM · Traditional | Fast Wrap Co., Inc. | 06/20/1983SE |
| K831551 | Compressogrip Tubular Elastic BandageFQM · Traditional | Fred Sammons, Inc. | 06/07/1983SE |
| K820142 | Tubular StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
| K820141 | Bias StockinetteFQM · Traditional | Stan-Pak Ent. | 02/05/1982SE |
More from Stan-Pak Ent.
| 510(k) | Device | Decision |
|---|---|---|
| K013239 | Comfortcare Compression Support with Magnets Comfortcare Magnetic InsolesFMQ · Traditional | 11/20/2001SE |
Questions and answers
When was Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe cleared by the FDA?
Comfortcare Compression Support Witih Magnets and Aegis Microbe Shield Comfortcare Magnetic Insoles and Aegis Microbe (K013244) received a 510(k) decision of Substantially Equivalent on December 7, 2001, 70 days after the submission was received.
What is the product code of K013244?
The FDA product code is FQM – Bandage, Elastic, a Class I (low risk) device regulated under 21 CFR 880.5075.